Objective: The aim of the present study is to investigate the effect of antioxidant polyphenol-rich pomegranate juice (PJ) supplementation for 5 weeks on patients with stable chronic obstructive pulmonary disease (COPD), since the oxidative stress plays a major role in the evolution and pathophysiology of COPD. Design: A randomized, double-blind, placebo-controlled trial was conducted. Subjects: A total of 30 patients with stable COPD were randomly distributed in two groups (15 patients each). Interventions: Both groups consumed either 400 ml PJ daily or matched placebo (synthetic orange-flavoured drink) for 5 weeks. Trolox Equivalent Antioxidant Capacity (TEAC) of PJ, blood parameters (14 haematological and 18 serobiochemical), respiratory function variables, bioavailability of PJ polyphenols (plasma and urine) and urinary isoprostane (8-iso-PGF 2a ) were evaluated. Results: The daily dose of PJ (containing 2.66 g polyphenols) provided 4 mmol/l TEAC. None of the polyphenols present in PJ were detected in plasma or in urine of volunteers. The most abundant PJ polyphenols, ellagitannins, were metabolized by the colonic microflora of COPD patients to yield two major metabolites in both plasma and urine (dibenzopyranone derivatives) with no TEAC. No differences were found (P40.05) between PJ and placebo groups for any of the parameters evaluated (serobiochemical and haematological), urinary 8-iso-PGF 2a , respiratory function variables and clinical symptoms of COPD patients. Conclusions: Our results suggest that PJ supplementation adds no benefit to the current standard therapy in patients with stable COPD. The high TEAC of PJ cannot be extrapolated in vivo probably due to the metabolism of its polyphenols by the colonic microflora. The understanding of the different bioavailability of dietary polyphenols is critical before claiming any antioxidantrelated health benefit. Sponsorship: 'Fundació n Séneca' (Murcia, Spain), Project PB/18/FS/02 and Spanish CICYT, Project AGL2003-02195.

BackgroundRilpivirine is a recently authorised antiretroviral. Adherence is essential in this kind of drug.PurposeTo evaluate treatment adherence with rilpivirine/emtricitabine/tenofovir (RPV/FTC/TDF) using the SMAQ questionnaire and pharmacy dispensing records (FDR) and the correlation between these in HIV/AIDS mono-infected patients.Material and methodsProspective observational study. We included patients treated with RPV/FTC/TDF from September 2013 until September 2014 with adherence data available of at least 3 months. Demographics data and reason for treatment were collected.Adherence was calculated across the SMAQ questionnaire (qualitative and semi-quantitative) and FRD, considering the patient adherent when any of these parameters was ≥95%. The correlation between the methods was assessed using the kappa (k) index.Results33 patients started treatment with RPV/FTC/TDF during the above-mentioned period. 21 were included in the study. 71% were men (average age: 40 ± 10 years). 38% were treatment-naïve and the rest were changes of therapeutic strategy (33% adverse reactions and 29% simplification of treatment strategies).26% of patients were considered adherent from a qualitative point of view in the SMAQ questionnaire, 76% from a semi-quantitative perspective and 95% via the FRD. The results between the three analysis only coincided in 6 patients.As for the results of k index, we observed the following strength of agreement: fair between the SMAQ quantitative and qualitative questionnaires (k = 0.22) and slight between the SMAQ qualitative questionnaire and FRD (k = 0.04) and between semi-quantitative SMAQ and FRD questionnaire (k = 0.01).ConclusionOur study highlights a low adherence to treatment obtained with the SMAQ questionnaire (both qualitative and semi-quantitative). It may be due to both the inflexibility of the questions and because of the patient assessment. These results could be improved through a pharmacist intervention in the monthly clinical review.Correlation between the three methods was low, so their use in isolation may give erroneous results in predicting adherence. However, with this way, “hidden” non-adherent patients (adherent FRD and non-adherent SMAQ) and “masked” non-adherent patients (non-adherent FRD and adherent SMAQ) could be detected.References and/or acknowledgementsNo conflict of interest.

BackgroundTrifluridine/tiparacile is the second oral treatment approved for patients with mCRC who have received fluoropyrimidine, oxaliplin- and irinotecan-based chemotherapy, an anti-VEGF biologic therapy and, if RAS wild-type, an anti-EGFR.PurposeTo evaluate the efficacy and safety of patients treated with trifluridine plus tipiracil in a tertiary hospital in real-world data.Material and methodsRetrospective descriptive observational study was conducted. We included all patients from when the expanded access programme was introduced in our hospital (April 2016) to September 2017. Measured variables included: age, sex, KRAS status, ECOG performance status, number of cycles (minimum of two cycles), number of prior lines of treatment for CRCM, progression-free survival (PFS), adverse effects and dose reduction.Response evaluation was performed according to RECIST version 1.1, and toxicity evaluation as defined by the NCI-CTCAE, version 4.0.ResultsThirty patients were included: 60% males and a median age of 64.2 years (41–77). 53.3% of cases were KRAS wild-type tumours and ECOG performance status was 0 in 15 patients. They had received a median of three lines of treatment prior to a median of 3.5 cycles of trifluridine/tipiracil.Regarding effectiveness, the median PFS in 19 patients was 4.2 months, there were three patients that still continue treatment with a PFS of 3 months, four patients were not evaluated: three due to clinical progression and one was a case of exitus. Finally, four patients were awaiting PET scan evaluation.Treatment-related adverse effects of any grade were reported in 83.3% of patients. The most common ones were fatigue (56.6%), neutropaenia (40%; grade IV: 13.3%), nausea (39.9%), diarrhoea (23.2%), neurotoxicity (10%) and gastrointestinal pain (10%). A total of 10 patients required dose reduction because of these events.ConclusionEffectiveness evaluation revealed a much longer PFS during routine clinical practice in comparison to the result reported in the pivotal trials (4.2 vs 2 months in the RECOURSE study). Differences in study sample, number of prior lines of treatment and/or re-treatment rate may explain this fact. The safety profile, in contrast, was similar to that described in the data sheet. More experience in the use of trifluridine/tiparacile is needed to confirm these great data.No conflict of interest

BackgroundAtrial fibrillation (AF) is a common clinical problem, particularly in the elderly. Dabigatran is indicated for the prevention of stroke and systemic embolism, and the reduction of vascular mortality for patients with non-valvular atrial AF. The recommended daily dose of dabigatran is 150 mg every 12 hours. However, in patients aged 80 or older the recommended dose is 110 mg every 12 hours due to a high bleeding risk.PurposeTo study how dabigatran is prescribed in patients aged 80 or older and determine the number of older patients with non-recommended dosages of dabigatran.Material and methodsObservational descriptive study. Field of study: two tertiary hospitals and their reference areas. The target population consisted of 6 75 000 people. From January 2017 to July 2017, patients with a dabigatran prescription under the national health system coverage were studied. For statistical comparisons, the Student’s t test was used.ResultsThe number of patients with dabigatran prescriptions in our region were 992. The average age of patients was 75.4 years and 51.4% were females. Prescriptions were divided into 150 mg (460 patients, average age 68.2 years and 56.5% were males) 110 mg (512 patients, average age 81.6 years, p<001 vs. 150 mg, and 58.2% were females) and 75 mg (20 patients, average age 81.3 years and 55% were females).Four hundred and nineteen patients aged 80 or older had dabigatran prescriptions. Doses prescribed were 150 mg (n=40, 9.5%), 110 mg (n=366; 87.4%) and 75 mg (n=13; 3.1%).ConclusionOur data shows that most of the patients aged 80 or older in our region consume lower doses of dabigatran. The average age of patients is significantly higher in 110 mg prescriptions versus 150 mg. However, 9.5% of older patients receive non-recommended dosages of dabigatran. Interventions to improve prescriptions in older people are required.No conflict of interest

BackgroundSecond-generation tyrosine kinase inhibitors(2G-TKI) have increased considerably over the past few years. Despite good and maintained results with imatinib, 2G-TKI have shown a growing trend in their use due to their quick and deep response. However, there is no clear positioning between nilotinib and dasatinib.PurposeTo analyse differences in the response according to the 2G-TKI used in front-line therapy in chronic myeloid leukaemia (CML) patients.Material and methodsDescriptive retrospective observational study conducted in a tertiary hospital. Patients with front-line therapy with nilotinib or dasatinib from June 2011 until April 2016 were included.Study variables were: sociodemographic (sex, age), clinical (time from diagnosis, p210 rearrangement, hydroxiurea cytoreduction, 2G-TKI, dosage regimen, time with TKI).Response was assessed in terms of molecular response and classified according to European Leukaemia Net (ELN) 2013 criteria.Degree of response at 3, 6 and 12 months according to 2G-TKI employed was analysed using the Mann–Witney U test.Timing to major molecular response (MMR) and major cytogenetic response (MCR), according to 2G-TKI were also tested using the Chi square test. Data were analysed with SPSS 19 software.ResultsTwenty-two patients received front-line 2G-TKI. Seventy seven per cent (n=17) were males, and mean age was 56.5 (±14.3). Median time since diagnosis was 33 months (2–57). p210 rearrangement was present in 18 of our patients (four had no available data). All of them received hydroxiurea.2G-TKI among our population were: 59% (n=13) nilotinib and 41% (n=9) dasatinib. Three patients required dose adjustment (one nilotinib, two dasatinib). Median time receiving TKI was 28.5 months (3–57).No significant differences were found in terms of degree and time to MMR or MCR between nilotinib and dasatinib in any point of the study (p>0.05).ConclusionOur results suggest that both 2G-ITK are reasonable options in front-line therapy, with fast and deep responses obtained. No significant differences were found between them among our population.Consequently, treatment choice should be done according to toxicity, comorbidities, clinician experience and dosage-regimen.No conflict of interest

BackgroundIn Spain, a therapeutic positioning report (TPR) for sacubitril valsartan indicates its use in adult patients for the treatment of symptomatic chronic heart failure and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤35%), elevated B-type natriuretic peptid (BNP) seric levels and patients previously treated well with standard of care therapy (ACE inhibitors/ARBs, beta-blockers, mineralcorticoid antagonists and diuretics).PurposeTo evaluate the suitability of sacubitril valsartan prescriptions to the recommendations in a health management area.Material and methodsRetrospective descriptive study including patients treated with sacubitril valsartan from September 2016 until July 2017.Variables considered were: sex, age, treatment with ACE inhibitors/ARBs, beta-blockers, mineralcorticoid antagonists and/or diuretics, dosage regimen, contraindications or intolerance to standard therapy, LVEF previous to sacubitril valsartan, dose escalation, dose reduction, discontinuation and cause of discontinuation.To evaluate the suitability of the prescriptions we analysed: intolerance/contraindications to standard therapy, therapy before change, dosage regimen, dose tritation and LEVF ≤35%. Audit data were sent to their prescriptors to review.For data compilation we used the Microstrategy® prescription database and medical records.ResultsFifty-three patients started treatment with sacubitril valsartan in the cited period. Median age was 66.6 years: 83% (n=44) were men.According to previous standard care received: seven patients (13.2%) had not received ACE inhibitors/ARBs and only six patients (11.3%) received optimal doses of these.As for beta-blockers, nine patients (16.98%) had not received them and only five patients (9.4%) had received the optimal dose. Regarding mineralcorticoid antagonist, 14 patients had not received them (26.4%) and three patients received the optimal dose. LVEF was >35% in 16 patients.Overall, none of our patients met all the predetermined conditions in the TPR. No intolerance or contraindication to standard therapy was notified.A correct dose tritation or appropiate periodic examination was made in only 16 patients (30%).During the considered period, one patient received a reduced dose for hypotension and 10 patients discontinued treatment: four lack of indication, one economic conditions, one death, two hypotension and one cardiac transplantation.ConclusionThe results show an inadequate use of sacubitril valsartan according to TPR indications in most cases. With this analysis we intend to improve sacubitril valsartan use in our reference area. Audits are an effective method to improve the rational use of medicines.No conflict of interest

BackgroundThromboembolic disease (TED) is a complex condition in which the interaction between genetic, acquired and environmental factors determines the onset of an episode.PurposeThis study aimed to assess the risk factors (RF) associated with TED in hospitalised patients.Material and methodsA retrospective, descriptive study was conducted in which hospitalised patients with TED from January 2015 to June 2015 were included. Variables included: age, sex, type of TED, previous events, hospitalisation duration, D-dimer elevation, obesity, renal impairment, tabaquism, cardiac and respiratory comorbidities, recent immobilisation or major surgery, family history/genetic predisposition, oncohaematologic history, and treatment with chemotherapy regimens, hormonal therapy, angiogenic agents or erythropoiesis stimulating factors (ESF).Data were obtained from electronic prescription software (APD-Prisma) and medical records.Results108 patients were analysed. There were 6.8 new cases per 1000 admitted patients during the study period. 55% were women. Mean age was 71 years (18–97). 20.3% presented previous TED. Median time of hospitalisation was 8 days (1–91). D-dimer elevation was observed in 63.8% with an average value of 6926.91 (2-48453) (26% absent data).Of 108 patients, 40.7% presented tabaquism, 22% respiratory complications, 21% cardiac comorbidities, 14.8% obesity and 11% renal impairment. Recent immobilisation or major surgery was noted in 27.8% and 4.6% of cases, respectively. A family history of TED or genetic predisposing mutations were present in 7.4%. Oncohaematologic history was observed in 24%. 8.3% received chemotherapy, 6.5% hormonal therapy and 6.5% ESF. No patient received angiogenic therapy. 28 days mortality was 7.4%.ConclusionAmong our studied population, the incidence of TED was an important issue that grew according to genetic, acquired or environmental factors, consistent with published data. RF evaluation is an essential measure during hospitalisation to minimise these events. Multidisciplinary active programmes for TED prevention should be available.No conflict of interest

Background As the result of Resolution SC 0403/10 of December 22, 2010 in the region of Andalucia (Spain) some medicines for outpatient treatment are no longer dispensed in community pharmacies but in hospital pharmacies, given that they require special surveillance, supervision and control. Purpose To determine the savings made by dispensing oral cytostatic drugs in a third-level hospital. Materials and methods Descriptive observational study of the oral cytostatics dispensed between December 2010 and March 2013. Data were collected from APD software. We determined: The total expenditure on dispensing cytostatics for out-patients, The percentage of this expenditure relative to the total expenditure on all oral medicines for outpatients, The cost savings, The most expensive active ingredients. Results The value of oral cytostatics totalled 6,731,547.87 € during the period of study. This meant 6.37% of the total amount of out-patient prescriptions for oral medicines for the same period. These prescriptions would have cost € 7,141,037.52 if they had been made at community pharmacies. Therefore, these results equate to a saving of € 409,489.64. The active ingredients that affected the cost most were imatinib and sunitinib. Conclusions Hospital dispensing of oral cytostatics led to a cost saving of 5.73% when compared to community pharmacy dispensing. Two factors explain this cost saving: The Avoidance of Any Commercial Expenditure Undertaken by Community Pharmacies The Optimisation of Resources Driven by Patients Taking the Exact Amount Needed of the Drug as They Are Required to Return Any Untaken Medicine When Completing or Changing Their Treatment No conflict of interest.